Association of Intestinal Microbiota and the Onset of Perianal Abscess Based on 16S RDNA Amplicon Sequencing

NCT05862129 | Completed

• 1 other identifier: 2022SF-369
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is tolearn the association of gut microflora with the onset of perianal abscesses. The main questions it aims to answer are: Question 1: To understand the structure of rectal microbial community composition and its relationship with pathogenic bacteria in patients with perianal abscess. Question 2: Understand the structure of rectal microbial community composition in healthy people. Participants will be collected with rectal secretions and stool specimens.In addition, patients with perianal abscess should also collect pus samples.

Conditions

Perianal Abscess

Outcome Measures

Primary Outcomes (2)

• Observation group: the structure and changes of rectal flora before and after treatment

  Analysis of the intestinal microflora based on 16S rDNA amplicon sequencing

  Two months

• Control group: the structure and changes of rectal flora in healthy population

  Analysis of the intestinal microflora based on 16S rDNA amplicon sequencing

  Two months

Study Arms (2)

observation group

This group will collect rectal secretions and stool samples and pus samples from patients with perianal abscess before treatment, and collect rectal secretions and stool samples from patients again 2 months after treatment according to the diagnosis and treatment guidelines.

Procedure: surgical operation

control group

This group collected rectal secretions and stool specimens from a healthy population.

Interventions

surgical operation PROCEDURE

Radical operation for the perianal abscess

observation group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Volunteers who did not keep the specimens as required

You may qualify if:

• Observation group: ① Age between 18-60 years, local resident of Xi'an; ② met the diagnostic criteria for perianal abscess and underwent surgical treatment in our hospital; ③ did not use antibiotics before treatment; ④ himself and his family members were willing to participate in this study and signed informed consent.
• Control group: ① Age between 18-60 years, permanent residents in Xi'an; ② had no serious chronic disease, no abnormality in physical examination in the last 1 week; ③ did not use drugs that may affect intestinal flora in the last one month; ④ himself and his family members are willing to participate in the study and sign the informed consent.

You may not qualify if:

• Failing to retain the specimens as required

Sponsors & Collaborators

• Xi'an Hospital of Traditional Chinese Medicine: lead

Study Sites (1)

Xi'an Hospital of Traditional Chinese Medicine

Xi'an, Shaanxi, 710021, China

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2023
• First Posted: May 17, 2023
• Study Start: June 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: January 7, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)